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  • Julie Barnes

July 2, 2020

Maverick Health Policy Update

Only What Matters On Health Information Policy

Happy July 4th to everyone and best wishes for figuring out how to celebrate our 244th anniversary of the Declaration of Independence from Great Britain, when neither country is in their “finest hour.” Maybe watch Hamilton?

  1. New post-pandemic digital health predictions and trends are here and here.

  2. HHS intends to extend the COVID-19 public health emergency for 90 days (the current PHE expires July 25th), which gives the HHS Office of Civil Rights (OCR) more time to update HIPAA before the pandemic-related enforcement discretion disappears -- as they said they will do in the recently released unified agenda. But don’t hold your breath -- OCR has been sitting on hundreds of suggestions on how to change HIPAA since the RFI comment period closed in February 2019, and there is so much more to consider with general federal data privacy laws under consideration.

  3. A new report found that telehealth services peaked in mid-April but are not as popular now, and the president of the Commonwealth Fund (a well-respected doctor and former National Coordinator of Health Information Technology) separately warns that telehealth works well for only some health care services.


One Thoughtful Paragraph


On the same day that CDC Director Robert Redfield asked Congress for a “substantial investment” in the “aggressive modernization” of a “comprehensive, integrated public health data system,” (see video of U.S. Senate HELP hearing at 2:12), the FDA held a virtual public meeting about how to modernize its data strategy. The FDA announced its Technology Modernization Action Plan (TMAP) back in September 2019, led by Vid Desai, the FDA’s Chief Technology Officer, and Principal Deputy Commissioner and Acting CIO Amy Abernathy. The idea is to not only update FDA’s hardware and software, but to “make sense of all of their data in efficient ways so they can aggregate critical and sensitive information across different drug applications and medical device applications.” (Abernathy quoted here, speaking at Health Datapalooza, February 2020). The public meeting featured three panels to explore how FDA can:

  • Unite data: how to use policy and common data standards to ensure the effective and efficient use of data assets

  • Improve data management: how can FDA modernize its data strategy to continue ensuring privacy and security

  • Use data properly: how can FDA design its data strategy to facilitate appropriate data access, sharing, and reuse and repurposing of data

Comments can be submitted on or before July 30, 2020. At least one expert thinks that it may take several years before the FDA is prepared to formalize and implement a new strategy. Because all of this builds on the 21st Century Cures Act of 2016 proposals to modernize the use of real world data in the approval of medical treatments, it has already taken several years to just get to a public conversation about it.

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Julie Barnes, J.D. 

Phone: (703) 304-1756 

Email: julie.barnes@maverickhealthpolicy.com

P.O. Box 7117 2200 N. George Mason Drive, Arlington, VA 22207

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